Major Depression Disorder associated with painful physical symptoms MedDRA version: 9.1 Level: LLT Classification code 10057840 Term: Major depression
Conditions
Interventions
Trade Name: Trittico retard 75 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Trazodon
CAS Number: 19794-93-5
Concentration unit: mg milligram(s)
Concentration type: equal
Trade Name: Trittico r
Sponsors
CSC Pharmaceuticals Handels GmbH.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject diagnosed Major Depression associated with painful physical symptoms, and fulfilling the following criteria: Concerning Painful physical symptoms: at least 1 month prior to study start presence of PPS. Global Pain m assessed by the patient must correspond to = 60 mm VAS at Visit 2. Concerning Major Depression: at least 1 month prior to study start diagnosis of Major Depression according to DSM-IV criteria Score 18 – 24 on the Hamilton Depression Rating Scale at Visit 2. Male or female outpatients aged 18-65 years If female of childbearing potential: must have negative (urine) pregnancy test at screnning visit and at Visit 5. Subject who, in the opinion of the investigator, would understand the meaning of the information sheet, would be co-operative and sufficiently reliable to use the medication as instructed, complete the diary and return for follow-up visits. Subject has provided written informed consent prior to undergoing any study procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study for any of the following reasons: Who is pregnant or breast-feeding. Who has a known hypersensitivity to trazodone, Who is suffering from known liver, kidney, cardiovascular, pulmonary or hematological disease Who is suffering from asthma. Who is suffering from cardiac malfunction Who is suffering from epilepsy Who is suffering from hypotension i.e. systolic blood pressure 90 mm HG or systolic > 140 mm HG Who is suffering from bradycardia with a frequency < 45 Who has suffered from an ulcer, gastrointestinal bleeding and/or perforation within 2 years prior to the trial. With evidence or history of drug or alcohol abuse. Who has previously participated in this clinical study or any other clinical study in the past 30 days With mental impairment limiting the ability to comply with study requirements Who, in the opinion of the investigator, is unable or unwilling to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to to asses the percentage of responders at week 5 with a combined reduction score of Pain (VAS = 50%) and Depression (HAM-D = 50%).;Primary end point(s): Percentage of responders at week 5 defined by a reduction of at least 50 % in the HAM-D score and with a reduction of at least 50 % in the VAS score ;Secondary Objective: Secondary objectives of the study are: To evaluate the Percentage of responders at week 7 and at week 9 defined by a reduction of = 50 % in the HAM-D score and with a reduction of = 50 % in the VAS score To evaluate the Safety of Trazodone in doses up to 450 mg To evaluate the pain disability compared to baseline and between Responders and Non-Responders To evaluate the pain perception compared to baseline and between Responders and Non-responders To evaluate the Quality of sleep compared to baseline and between Responders and Non-Responders To evaluate the most effective dose in relation to Depression and Pain To evaluate the amount/consumption of rescue medication To evaluate the course of depression measured by HAM-D compared to baseline To evaluate the course of pain measured by VAS compared to baseline | — |
Countries
Austria
Outcome results
None listed